- Applies to: Any UF IRB Submissions Involving Human Subjects and Services
- Effective date: 11/02/09
Studies that involve human subjects and services (regardless of service location, sponsor, or payer) have to be evaluated by the Office of Clinical Research (OCR) for billing compliance risk and Informed Consent financial language recommendations before IRB submission.
This process is required for any human subject studies where the BOTH of the following criteria apply:
1) The study involves a UF Principal Investigator and activities conducted in a Gainesville Health Science Center (HSC) facility.
Examples of Gainesville HSC facilities include, but are not limited to:
- Shands Hospital
- Shands Ancillary Departments (e.g. lab, radiology, etc.)
- Shands/UF Clinic Space
- UF Core Labs
- HSC Communicore Building
- HSC Medical Science Building
- HSC Academic Research Building
- HPNP
- CTRB Building (includes Aging and CTSI)
- McKnight Brain Institute
- CTSI Clinical Research Centers (e.g. UF CRC)
AND
2) The study also involves any of the following:
- the use of any IND drugs or IDE devices
- any services that generate a charge in a UF Health patient billing system (e.g. Epic)
- research-only standalone visits in a Shands facility or UF clinic
- research-only activity that prolongs patient encounters that are billed according to time (e.g. surgical procedures, anesthesiology services etc.)
- research services that will be performed by Shands personnel, including hospital nurses and other professional/technical staff
- an outside sponsor who is willing to pay for subject injury